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Stop Exogenous Allergic Alveolitis (EAA) in Childhood

NCT02631603 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 4

Last updated 2024-12-18

Study results available
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Summary

Stop exogenous allergic alveolitis (EAA) or hypersensitivity pneumonitis in childhood: healthy into adulthood - a randomized, double-blind, placebo-controlled, parallel-group study to evaluate prednisolone treatment and course of disease.

The hypothesis of the study is that the treatment with placebo will not be inferior in terms of Forced Vital Capacity (FVC) improvement than treatment with systemic steroids after 6 months treatment.

Conditions

  • Hypersensitivity Pneumonitis
  • Exogenous Allergic Alveolitis

Interventions

DRUG

Placebo

Administer Placebo as anti-inflammatory

DRUG

Prednisolone

Administer Prednisolone as anti-inflammatory

Sponsors & Collaborators

  • Matthias Griese

    lead OTHER

Principal Investigators

  • Matthias Griese, Prof., MD · Pediatric Pneumology, Ludwig-Maximilians-University Munich

  • Meike Hengst, MD · Pediatric Pneumology, Ludwig-Maximilians University Munich

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2016-07-11
Completion
2020-06-16

Countries

  • Germany

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02631603 on ClinicalTrials.gov